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Do Antidepressants Induce Metabolic Syndromes METADAP Study (METADAP)

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ClinicalTrials.gov Identifier: NCT00526383
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : April 17, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1 antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes is a matter of concern.

The main objective of this study is to assess the differential impact of antidepressants in terms of weight gain and metabolic syndromes.


Condition or disease Intervention/treatment
Major Depressive Disorder Drug: Tricyclic antidepressants

Detailed Description:

Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1 antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes is a matter of concern.

The main objective of this study is to assess the differential impact of antidepressants in terms of weight gain and metabolic syndromes.

Prospective 6-month naturalistic cohort study, comparing 4 classes of antidepressants (SSRIs, SNRIs, TCAs and others) to a control group (ECT and r-TMS), in 600 patients with a major depressive disorder requiring the beginning of either antidepressant or ECT/r-TMS treatment.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 624 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Do Antidepressants Induce Metabolic Syndromes
Study Start Date : November 2007
Primary Completion Date : April 2013
Study Completion Date : April 2013


Arms and Interventions

Arm Intervention/treatment
Experimental: A
antidepressant versus medical dispositive
Drug: Tricyclic antidepressants
antidepressant version medical dispositive
Other Name: antidepressant version medical dispositive
Placebo Comparator: B Drug: Tricyclic antidepressants
antidepressant version medical dispositive
Other Name: antidepressant version medical dispositive


Outcome Measures

Primary Outcome Measures :
  1. Definition criteria of the metabolic syndromes: Weight and waist circumference Systolic and diastolic blood pressure Glycemia Triglyceridemia Cholesterolemia Insulinemia [ Time Frame: at Months 0, 1, 3, 6 ]

Secondary Outcome Measures :
  1. Antidepressant efficacy (HAM-D, quickIDS-C, quickIDS-SR, CGI) [ Time Frame: at Months 0, 1, 3, 6 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age : 18-70
  • Current major depressive episode (Major depressive disorder) based on the MINI interview
  • HAM-D >18
  • Requiring either antidepressant treatment, either ECT or r-TMS (as assessed by the clinician)
  • Signed informed consent

Exclusion Criteria:

  • Bipolar disorder (DSM-IV), Psychotic disorder (DSM-IV), Substance abuse or dependence (DSM-IV)
  • Normothymic treatment
  • Antipsychotic treatment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526383


Locations
France
Assistance Publique hopital Bicêtre
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Emmanuelle CORRUBLE, MD PhD Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00526383     History of Changes
Other Study ID Numbers: P060219
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: September 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Major depressive disorder
Antidepressants
Weight gain
Metabolic syndromes

Additional relevant MeSH terms:
Depressive Disorder
Depression
Metabolic Syndrome X
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antidepressive Agents
Antidepressive Agents, Tricyclic
Psychotropic Drugs